{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2931-s1", "verdict_number": "2931", "title": "Evidence sheet: added ribociclib × overall survival — distinguishing immature data from iDFS", "view_version": "1.0", "view_created_date": "2026-10-10", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "The entire existing review summary was read for preparation and existing links and identifiers were connected. No new URLs or bibliography were created for PALLAS or monarchE, whose bibliography is absent. External abstracts, full texts, registration, protocols and SAP were not newly read or checked.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "Stage 2 or 3 HR-positive, HER2-negative early breast cancer; original NATALEE eligibility and baseline details unread", "intervention": "Historical study exposure to ribociclib plus endocrine therapy; no treatment-selection recommendation", "dose": "The original 400 mg, 3 weeks on/1 week off, 3 years and population-specific goserelin are preserved as historical stored-summary records; no dose, administration or suitability instructions are created", "comparator": "Endocrine therapy alone; other-drug trials contrast within-class results and are not direct comparisons between drugs", "endpoint": "The claim of longer overall survival; subclaim D and immaturity preserved, without filling gaps with iDFS or other-drug results", "duration": "Distinguishing 3-year iDFS estimates, 3-year planned exposure and final median follow-up of 33.3 months; OS-specific follow-up and maturity details unread", "excluded_extensions": [ "Converting composite iDFS events to OS, cure or permanent prevention", "Adding interim or final reports and other drugs as independent replication of ribociclib", "Combining 3-year estimates, planned exposure and median follow-up of 33.3 months", "Copying effects of other drugs into ribociclib OS values", "Recommendations on treatment, dose, monitoring or suitability" ] }, "requirements": [ { "item_id": "N01", "question_type": "Comparative efficacy", "question": "Are the original subclaim and grade distinguished from the parent judgment context?", "needed": "Separate preservation of the selected question, grade and note and the original parent judgment", "role": "Required", "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries", "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.", "criterion": "Separate preservation of the selected question, grade and note and the original parent judgment", "basis": "Longer overall survival", "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions", "proposed_research": "Link additional materials separately to the selected question and the parent context.", "current_reports": [ "R01", "R02" ], "existence": "Material information recorded in the preserved review summary", "acquired_read": "Summary read; external materials not read", "observation": "The selected existing claim is ‘Longer overall survival’, with subclaim grade D and the note that the data remain immature. The parent is B, 76 points and Caution.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials remain unread and review of existing content remains incomplete. Absent subclaim score, status and axes are not filled with parent values. No new judgment, blanket D grade or independence certification is provided.", "missingness": "Absent subclaim score, status and axes are not filled with parent values. No new judgment, blanket D grade or independence certification is provided.", "uncertainty": "Unread, immature or unverified does not mean zero effect, zero events, safety or a new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Absent subclaim score, status and axes are not filled with parent values. No new judgment, blanket D grade or independence certification is provided." }, { "item_id": "N02", "question_type": "Comparative efficacy", "question": "What is the actual early-breast-cancer population and scope of baseline conditions?", "needed": "Original eligibility, HR/HER2, stage, sex, baseline characteristics and denominators", "role": "Required", "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries", "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.", "criterion": "Original eligibility, HR/HER2, stage, sex, baseline characteristics and denominators", "basis": "Longer overall survival", "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions", "proposed_research": "Obtain original eligibility, baseline, previous-treatment and group-specific participant materials.", "current_reports": [ "R01", "R02" ], "existence": "Material information recorded in the preserved review summary", "acquired_read": "Summary read; external materials not read", "observation": "NATALEE is an international phase 3 trial comparing added ribociclib in stage 2 or 3 HR-positive, HER2-negative early breast cancer.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials remain unread and review of existing content remains incomplete. The summary lacks details of nodal status, detailed risk eligibility, baseline treatment, population composition and original group denominators. Findings are not extended to metastatic cancer or other stages or types.", "missingness": "The summary lacks details of nodal status, detailed risk eligibility, baseline treatment, population composition and original group denominators. Findings are not extended to metastatic cancer or other stages or types.", "uncertainty": "Unread, immature or unverified does not mean zero effect, zero events, safety or a new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The summary lacks details of nodal status, detailed risk eligibility, baseline treatment, population composition and original group denominators. Findings are not extended to metastatic cancer or other stages or types." }, { "item_id": "N03", "question_type": "Comparative efficacy", "question": "What is the actual comparison between added treatment and endocrine therapy alone?", "needed": "Original intervention and comparator, shared endocrine therapy, concomitant treatment and actual exposure", "role": "Required", "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries", "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.", "criterion": "Original intervention and comparator, shared endocrine therapy, concomitant treatment and actual exposure", "basis": "Longer overall survival", "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions", "proposed_research": "Obtain original group-specific interventions, shared endocrine therapy, concomitant treatment and changes.", "current_reports": [ "R01", "R02" ], "existence": "Material information recorded in the preserved review summary", "acquired_read": "Summary read; external materials not read", "observation": "Ribociclib plus endocrine therapy was compared with endocrine therapy alone. Existing topic classifications preserve aromatase inhibitors and endocrine therapy.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials remain unread and review of existing content remains incomplete. This is not converted to ribociclib alone, ineffectiveness of endocrine therapy or direct superiority over other drugs. Original tables on specific endocrine drugs, concomitant treatment and exposure changes have not been read.", "missingness": "This is not converted to ribociclib alone, ineffectiveness of endocrine therapy or direct superiority over other drugs. Original tables on specific endocrine drugs, concomitant treatment and exposure changes have not been read.", "uncertainty": "Unread, immature or unverified does not mean zero effect, zero events, safety or a new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "This is not converted to ribociclib alone, ineffectiveness of endocrine therapy or direct superiority over other drugs. Original tables on specific endocrine drugs, concomitant treatment and exposure changes have not been read." }, { "item_id": "N04", "question_type": "Comparative efficacy", "question": "Are the study dose and 3-year plan distinguished from actual treatment completion?", "needed": "Original study exposure, planned duration, actual adherence, reduction or discontinuation, and denominators", "role": "Required", "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries", "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.", "criterion": "Original study exposure, planned duration, actual adherence, reduction or discontinuation, and denominators", "basis": "Longer overall survival", "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions", "proposed_research": "Obtain original plans, actual exposure, completion, discontinuation, dose reduction and denominators.", "current_reports": [ "R01", "R02" ], "existence": "Material information recorded in the preserved review summary", "acquired_read": "Summary read; external materials not read", "observation": "The original conditions were a study plan of 400 mg for 3 weeks on and 1 week off, repeated for 3 years. This is historical exposure preserved in the existing review summary.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials remain unread and review of existing content remains incomplete. This does not certify that all participants completed 3 years or advise individuals on dose, schedule or treatment. Distributions of actual treatment, adherence, discontinuation and dose reduction have not been read.", "missingness": "This does not certify that all participants completed 3 years or advise individuals on dose, schedule or treatment. Distributions of actual treatment, adherence, discontinuation and dose reduction have not been read.", "uncertainty": "Unread, immature or unverified does not mean zero effect, zero events, safety or a new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "This does not certify that all participants completed 3 years or advise individuals on dose, schedule or treatment. Distributions of actual treatment, adherence, discontinuation and dose reduction have not been read." }, { "item_id": "N05", "question_type": "Comparative efficacy", "question": "Is concomitant exposure in premenopausal women and men recorded separately?", "needed": "Population-specific concomitant treatment, original denominators, actual exposure and analyses", "role": "Required", "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries", "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.", "criterion": "Population-specific concomitant treatment, original denominators, actual exposure and analyses", "basis": "Longer overall survival", "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions", "proposed_research": "Obtain population-specific shared or added exposure, denominators and prespecified-analysis materials.", "current_reports": [ "R01", "R02" ], "existence": "Material information recorded in the preserved review summary", "acquired_read": "Summary read; external materials not read", "observation": "The existing review summary states that premenopausal women and men also received goserelin.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials remain unread and review of existing content remains incomplete. This is not converted to a goserelin-only effect, identical exposure for everyone or individual treatment suitability. Population-specific group denominators, original effects and interactions have not been read.", "missingness": "This is not converted to a goserelin-only effect, identical exposure for everyone or individual treatment suitability. Population-specific group denominators, original effects and interactions have not been read.", "uncertainty": "Unread, immature or unverified does not mean zero effect, zero events, safety or a new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "This is not converted to a goserelin-only effect, identical exposure for everyone or individual treatment suitability. Population-specific group denominators, original effects and interactions have not been read." }, { "item_id": "N06", "question_type": "Comparative efficacy", "question": "What are the 5,101 randomized participants and outcome-specific denominators or risk sets?", "needed": "Randomization, original group counts, ITT, follow-up and outcome-specific denominators", "role": "Required", "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries", "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.", "criterion": "Randomization, original group counts, ITT, follow-up and outcome-specific denominators", "basis": "Longer overall survival", "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions", "proposed_research": "Obtain original participant flow, group allocation, ITT, risk sets, censoring and denominators.", "current_reports": [ "R01", "R02" ], "existence": "Material information recorded in the preserved review summary", "acquired_read": "Summary read; external materials not read", "observation": "NATALEE randomized 5,101 participants; the existing review summary records 1:1 allocation and ITT analysis.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials remain unread and review of existing content remains incomplete. No new group counts, total events, dropout rates or risk sets are calculated. The original ITT description alone does not newly certify outcome-specific missingness or complete follow-up.", "missingness": "No new group counts, total events, dropout rates or risk sets are calculated. The original ITT description alone does not newly certify outcome-specific missingness or complete follow-up.", "uncertainty": "Unread, immature or unverified does not mean zero effect, zero events, safety or a new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "No new group counts, total events, dropout rates or risk sets are calculated. The original ITT description alone does not newly certify outcome-specific missingness or complete follow-up." }, { "item_id": "N07", "question_type": "Comparative efficacy", "question": "Are the original roles of open-label design, central allocation and objective events distinguished?", "needed": "Allocation, concealment, adjudicators, blinding and event ascertainment", "role": "Required", "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries", "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.", "criterion": "Allocation, concealment, adjudicators, blinding and event ascertainment", "basis": "Longer overall survival", "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions", "proposed_research": "Obtain original allocation, ascertainment, adjudication, analysis, censoring and bias materials.", "current_reports": [ "R01", "R02" ], "existence": "Material information recorded in the preserved review summary", "acquired_read": "Summary read; external materials not read", "observation": "The existing review summary records a central interactive allocation system, 1:1 allocation, open-label design, objective recurrence, invasive cancer or death events, and ITT as historical B0 evidence.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials remain unread and review of existing content remains incomplete. This is not converted into a new certification of blinding in all assessment or analysis, or absence of bias. Original procedural details have not been read externally.", "missingness": "This is not converted into a new certification of blinding in all assessment or analysis, or absence of bias. Original procedural details have not been read externally.", "uncertainty": "Unread, immature or unverified does not mean zero effect, zero events, safety or a new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "This is not converted into a new certification of blinding in all assessment or analysis, or absence of bias. Original procedural details have not been read externally." }, { "item_id": "N08", "question_type": "Comparative efficacy", "question": "Are the composite iDFS events distinguished from overall survival?", "needed": "Original STEEP definition, components, people or events, all-cause death and duration", "role": "Required", "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries", "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.", "criterion": "Original STEEP definition, components, people or events, all-cause death and duration", "basis": "Longer overall survival", "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions", "proposed_research": "Obtain original STEEP definitions, component-specific events, overall survival, durations and denominators separately.", "current_reports": [ "R01", "R02" ], "existence": "Material information recorded in the preserved review summary", "acquired_read": "Summary read; external materials not read", "observation": "The original primary endpoint is STEEP v1.0 iDFS, a composite of recurrence, invasive cancer and death. The stored summary records overall-survival data as still immature.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials remain unread and review of existing content remains incomplete. Reduction in composite events is not transferred to reduced all-cause death, longer survival time or definite cure. Original tables of individual components and all-cause deaths have not been read.", "missingness": "Reduction in composite events is not transferred to reduced all-cause death, longer survival time or definite cure. Original tables of individual components and all-cause deaths have not been read.", "uncertainty": "Unread, immature or unverified does not mean zero effect, zero events, safety or a new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Reduction in composite events is not transferred to reduced all-cause death, longer survival time or definite cure. Original tables of individual components and all-cause deaths have not been read." }, { "item_id": "N09", "question_type": "Comparative efficacy", "question": "Are the interim 3-year survival rates, HR, CI and two-sided P preserved as recorded?", "needed": "Original analysis timing, 3-year estimates, HR, CI, tests and denominators", "role": "Required", "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries", "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.", "criterion": "Original analysis timing, 3-year estimates, HR, CI, tests and denominators", "basis": "Longer overall survival", "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions", "proposed_research": "Obtain original estimation methods, group risk sets, censoring, denominators, CI and models.", "current_reports": [ "R01", "R02" ], "existence": "Material information recorded in the preserved review summary", "acquired_read": "Summary read; external materials not read", "observation": "At interim analysis, 3-year iDFS was 90.4% versus 87.1%, HR 0.75(95% CI 0.62~0.91), two-sided P=.003.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials remain unread and review of existing content remains incomplete. Survival rates are not converted to simple event proportions or OS values. No new absolute difference, NNT, risk ratio, reversed HR or P value is calculated.", "missingness": "Survival rates are not converted to simple event proportions or OS values. No new absolute difference, NNT, risk ratio, reversed HR or P value is calculated.", "uncertainty": "Unread, immature or unverified does not mean zero effect, zero events, safety or a new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Survival rates are not converted to simple event proportions or OS values. No new absolute difference, NNT, risk ratio, reversed HR or P value is calculated." }, { "item_id": "N10", "question_type": "Comparative efficacy", "question": "Are the prespecified one-sided boundary and two-sided P distinguished?", "needed": "Protocol, interim analysis, test direction, alpha spending, boundary and changes", "role": "Required", "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries", "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.", "criterion": "Protocol, interim analysis, test direction, alpha spending, boundary and changes", "basis": "Longer overall survival", "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions", "proposed_research": "Obtain original interim-analysis plans, boundaries, direction, alpha spending and change history.", "current_reports": [ "R01", "R02" ], "existence": "Material information recorded in the preserved review summary", "acquired_read": "Summary read; external materials not read", "observation": "The existing review summary records two-sided P=.003 and the protocol's one-sided P<.0128 boundary, stating that the prespecified superiority boundary was crossed.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials remain unread and review of existing content remains incomplete. Two-sided and one-sided values are not made identical, and no new test, boundary or exemption from multiplicity is certified. Original registration, planning and boundary documents have not been read.", "missingness": "Two-sided and one-sided values are not made identical, and no new test, boundary or exemption from multiplicity is certified. Original registration, planning and boundary documents have not been read.", "uncertainty": "Unread, immature or unverified does not mean zero effect, zero events, safety or a new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Two-sided and one-sided values are not made identical, and no new test, boundary or exemption from multiplicity is certified. Original registration, planning and boundary documents have not been read." }, { "item_id": "N11", "question_type": "Comparative efficacy", "question": "Are the final 33.3-month analysis and 226/283 events distinguished from interim values?", "needed": "Analysis cutoff date, follow-up statistics, events, original effects and denominators", "role": "Required", "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries", "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.", "criterion": "Analysis cutoff date, follow-up statistics, events, original effects and denominators", "basis": "Longer overall survival", "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions", "proposed_research": "Obtain original analysis cutoffs, follow-up distributions, risk sets, models and event mapping.", "current_reports": [ "R01", "R02" ], "existence": "Material information recorded in the preserved review summary", "acquired_read": "Summary read; external materials not read", "observation": "The prespecified final analysis had median follow-up of 33.3 months, 226 versus 283 events, HR 0.749(95% CI 0.628~0.892), P=.0012.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials remain unread and review of existing content remains incomplete. Median follow-up of 33.3 months is not equated with the time point of the 3-year survival estimate, and events from the two reports are not added. No new final 3-year rate, event total or OS result is created.", "missingness": "Median follow-up of 33.3 months is not equated with the time point of the 3-year survival estimate, and events from the two reports are not added. No new final 3-year rate, event total or OS result is created.", "uncertainty": "Unread, immature or unverified does not mean zero effect, zero events, safety or a new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Median follow-up of 33.3 months is not equated with the time point of the 3-year survival estimate, and events from the two reports are not added. No new final 3-year rate, event total or OS result is created." }, { "item_id": "N12", "question_type": "Comparative efficacy", "question": "Are interim and final reports kept from being added as new independent confirmation?", "needed": "The same trial and population, follow-up reports, individual outcomes and sibling-sheet relationships", "role": "Required", "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries", "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.", "criterion": "The same trial and population, follow-up reports, individual outcomes and sibling-sheet relationships", "basis": "Longer overall survival", "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions", "proposed_research": "Connect additional reports through original registration, population, timing and overlap relationships.", "current_reports": [ "R01", "R02" ], "existence": "Material information recorded in the preserved review summary", "acquired_read": "Summary read; external materials not read", "observation": "The Slamon2024 interim report and Hortobagyi2025 final report concern the same NATALEE trial. The stored summary records one confirmatory trial of ribociclib itself.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials remain unread and review of existing content remains incomplete. The 2 reports, follow-up and two subclaim outcomes are not added as new independent trials or participants. Final independent and participant totals are not recorded.", "missingness": "The 2 reports, follow-up and two subclaim outcomes are not added as new independent trials or participants. Final independent and participant totals are not recorded.", "uncertainty": "Unread, immature or unverified does not mean zero effect, zero events, safety or a new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The 2 reports, follow-up and two subclaim outcomes are not added as new independent trials or participants. Final independent and participant totals are not recorded." }, { "item_id": "N13", "question_type": "Comparative efficacy", "question": "What gaps remain in overall-survival event maturity, effects, CI, P and hierarchy?", "needed": "Original deaths, follow-up, OS effect of interest, denominators, plans and maturity", "role": "Required", "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries", "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.", "criterion": "Original deaths, follow-up, OS effect of interest, denominators, plans and maturity", "basis": "Longer overall survival", "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions", "proposed_research": "Obtain original OS events, denominators, follow-up, prespecified hierarchy, boundaries, models and CI.", "current_reports": [ "R01", "R02" ], "existence": "Material information recorded in the preserved review summary", "acquired_read": "Summary read; external materials not read", "observation": "The note for the longer-overall-survival subclaim states that the data remain immature. The existing review summary and safety text preserve this limitation.", "condition_status": "Unverified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials remain unread and review of existing content remains incomplete. The 226/283 iDFS events, HR or CI are not used to fill OS events or effects. The summary lacks OS deaths, HR, CI, P, information fraction and cutoff date. Immaturity is not converted to a definite zero effect.", "missingness": "The 226/283 iDFS events, HR or CI are not used to fill OS events or effects. The summary lacks OS deaths, HR, CI, P, information fraction and cutoff date. Immaturity is not converted to a definite zero effect.", "uncertainty": "Unread, immature or unverified does not mean zero effect, zero events, safety or a new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The 226/283 iDFS events, HR or CI are not used to fill OS events or effects. The summary lacks OS deaths, HR, CI, P, information fraction and cutoff date. Immaturity is not converted to a definite zero effect." }, { "item_id": "N14", "question_type": "Comparative efficacy", "question": "Is the absence of direct overall-survival materials kept from being filled with iDFS or other-drug results?", "needed": "Direct OS events, denominators, models, CI, timing and maturity", "role": "Required", "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries", "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.", "criterion": "Direct OS events, denominators, models, CI, timing and maturity", "basis": "Longer overall survival", "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions", "proposed_research": "Connect mature original direct OS reports, plans, timing, denominators and effects of interest separately.", "current_reports": [ "R01", "R02" ], "existence": "Material information recorded in the preserved review summary", "acquired_read": "Summary read; external materials not read", "observation": "The selected existing claim concerns longer overall survival, but the subclaim's D grade and immaturity note are preserved. The numbers in the original stored summary concern NATALEE iDFS and iDFS for other drugs.", "condition_status": "Unverified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials remain unread and review of existing content remains incomplete. Death within the same composite, other-drug results, extended follow-up or mechanisms do not substitute for OS effects. No new deaths, HR, CI, denominators or zero-effect judgment are provided.", "missingness": "Death within the same composite, other-drug results, extended follow-up or mechanisms do not substitute for OS effects. No new deaths, HR, CI, denominators or zero-effect judgment are provided.", "uncertainty": "Unread, immature or unverified does not mean zero effect, zero events, safety or a new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Death within the same composite, other-drug results, extended follow-up or mechanisms do not substitute for OS effects. No new deaths, HR, CI, denominators or zero-effect judgment are provided." }, { "item_id": "N15", "question_type": "Comparative efficacy", "question": "Are actual exposure completion, survival follow-up and long-term persistence distinguished?", "needed": "Planned exposure, actual completion, follow-up duration and post-discontinuation outcomes", "role": "Required", "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries", "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.", "criterion": "Planned exposure, actual completion, follow-up duration and post-discontinuation outcomes", "basis": "Longer overall survival", "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions", "proposed_research": "Obtain original actual exposure, follow-up, censoring and long-term outcomes after discontinuation.", "current_reports": [ "R01", "R02" ], "existence": "Material information recorded in the preserved review summary", "acquired_read": "Summary read; external materials not read", "observation": "The original intervention plan was 3 years, while median follow-up in the final iDFS analysis was 33.3 months; these are different time descriptions.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials remain unread and review of existing content remains incomplete. These two durations are not combined as identical treatment or follow-up for everyone, or a persistent long-term effect after treatment ends.", "missingness": "These two durations are not combined as identical treatment or follow-up for everyone, or a persistent long-term effect after treatment ends.", "uncertainty": "Unread, immature or unverified does not mean zero effect, zero events, safety or a new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "These two durations are not combined as identical treatment or follow-up for everyone, or a persistent long-term effect after treatment ends." }, { "item_id": "N16", "question_type": "Comparative efficacy", "question": "Do information gaps remain for subgroups, stage or sex application, and multiplicity?", "needed": "Prespecified subgroups, interactions, models, original denominators and effects", "role": "Required", "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries", "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.", "criterion": "Prespecified subgroups, interactions, models, original denominators and effects", "basis": "Longer overall survival", "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions", "proposed_research": "Obtain prespecified subgroup, interaction, denominator, CI and multiplicity materials.", "current_reports": [ "R01", "R02" ], "existence": "Material information recorded in the preserved review summary", "acquired_read": "Summary read; external materials not read", "observation": "The original population was stage 2 or 3 HR-positive, HER2-negative disease; concomitant goserelin exposure in premenopausal women and men is recorded.", "condition_status": "Unverified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials remain unread and review of existing content remains incomplete. No new population-specific effects, drug suitability, individual predictions or prespecified interaction results are created. Detailed subgroup plans, original denominators and multiplicity have not been read.", "missingness": "No new population-specific effects, drug suitability, individual predictions or prespecified interaction results are created. Detailed subgroup plans, original denominators and multiplicity have not been read.", "uncertainty": "Unread, immature or unverified does not mean zero effect, zero events, safety or a new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "No new population-specific effects, drug suitability, individual predictions or prespecified interaction results are created. Detailed subgroup plans, original denominators and multiplicity have not been read." }, { "item_id": "N17", "question_type": "Comparative efficacy", "question": "What are the other drug, trial and level of wording in PALLAS?", "needed": "Palbociclib population, intervention, comparison, denominators, original effects and bibliography", "role": "Required", "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries", "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.", "criterion": "Palbociclib population, intervention, comparison, denominators, original effects and bibliography", "basis": "Longer overall survival", "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions", "proposed_research": "Obtain original PALLAS reports, population, comparison, effects, duration, denominators and bibliography separately.", "current_reports": [ "R01", "R02", "R04" ], "existence": "Material information recorded in the preserved review summary", "acquired_read": "Summary read; external materials not read", "observation": "PALLAS is summarized in the stored record as a phase 3 trial with 5,796 participants, Pfizer and cooperative study groups, and no added benefit from palbociclib.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials remain unread and review of existing content remains incomplete. It is not used as direct replication of ribociclib or a direct comparison of superiority between drugs. Detailed PALLAS effects, CI, P, duration, eligibility and a separate citation link are absent from the existing review summary.", "missingness": "It is not used as direct replication of ribociclib or a direct comparison of superiority between drugs. Detailed PALLAS effects, CI, P, duration, eligibility and a separate citation link are absent from the existing review summary.", "uncertainty": "Unread, immature or unverified does not mean zero effect, zero events, safety or a new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "It is not used as direct replication of ribociclib or a direct comparison of superiority between drugs. Detailed PALLAS effects, CI, P, duration, eligibility and a separate citation link are absent from the existing review summary." }, { "item_id": "N18", "question_type": "Comparative efficacy", "question": "Are the repeated CI, drug and original comparison scope of PENELOPE-B preserved?", "needed": "Original drug, double blinding, placebo, effects, repeated CI and denominators", "role": "Required", "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries", "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.", "criterion": "Original drug, double blinding, placebo, effects, repeated CI and denominators", "basis": "Longer overall survival", "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions", "proposed_research": "Obtain original repeated CI, plans, population, follow-up, denominators and effects.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Material information recorded in the preserved review summary", "acquired_read": "Summary read; external materials not read", "observation": "PENELOPE-B was a double-blind, placebo-controlled phase 3 palbociclib trial with 1,250 participants, HR 0.93(95% repeated CI 0.74~1.17), P=.525.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials remain unread and review of existing content remains incomplete. The repeated CI is not newly certified as the same analysis as an ordinary CI, and these values do not replace ribociclib OS or iDFS. Original follow-up, eligibility and planning details have not been read.", "missingness": "The repeated CI is not newly certified as the same analysis as an ordinary CI, and these values do not replace ribociclib OS or iDFS. Original follow-up, eligibility and planning details have not been read.", "uncertainty": "Unread, immature or unverified does not mean zero effect, zero events, safety or a new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The repeated CI is not newly certified as the same analysis as an ordinary CI, and these values do not replace ribociclib OS or iDFS. Original follow-up, eligibility and planning details have not been read." }, { "item_id": "N19", "question_type": "Comparative efficacy", "question": "Are monarchE's other drug and 4-year results distinguished from NATALEE?", "needed": "Original drug, population, duration, denominators, effects and independent relationships", "role": "Required", "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries", "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.", "criterion": "Original drug, population, duration, denominators, effects and independent relationships", "basis": "Longer overall survival", "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions", "proposed_research": "Obtain original monarchE bibliography, eligibility, comparison, duration, effects and plans separately.", "current_reports": [ "R01", "R02", "R05" ], "existence": "Material information recorded in the preserved review summary", "acquired_read": "Summary read; external materials not read", "observation": "The existing review summary records monarchE as an abemaciclib trial with 5,637 participants, 4-year rates 85.8% versus 79.4%, HR 0.664(95% CI 0.578~0.762), supported by Eli Lilly.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials remain unread and review of existing content remains incomplete. These values do not fill ribociclib's 4-year or OS results or create a direct superiority or equivalence comparison between drugs. A separate citation link, original P value and detailed eligibility are absent from the existing review summary.", "missingness": "These values do not fill ribociclib's 4-year or OS results or create a direct superiority or equivalence comparison between drugs. A separate citation link, original P value and detailed eligibility are absent from the existing review summary.", "uncertainty": "Unread, immature or unverified does not mean zero effect, zero events, safety or a new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "These values do not fill ribociclib's 4-year or OS results or create a direct superiority or equivalence comparison between drugs. A separate citation link, original P value and detailed eligibility are absent from the existing review summary." }, { "item_id": "N20", "question_type": "Comparative efficacy", "question": "Are different within-class results kept from becoming a class-wide effect or new independent replication?", "needed": "Drug-specific questions, eligibility, comparators, durations and report or participant relationships", "role": "Required", "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries", "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.", "criterion": "Drug-specific questions, eligibility, comparators, durations and report or participant relationships", "basis": "Longer overall survival", "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions", "proposed_research": "Obtain drug-specific direct questions, original eligibility, duration, comparators and overlap relationships.", "current_reports": [ "R01", "R02", "R03", "R04", "R05" ], "existence": "Material information recorded in the preserved review summary", "acquired_read": "Summary read; external materials not read", "observation": "The stored summary contrasts two null palbociclib trials with positive ribociclib NATALEE and abemaciclib monarchE results, limiting generalization across drugs.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials remain unread and review of existing content remains incomplete. Positive or null results for other drugs are not used as independent NATALEE replication, zero ribociclib effect, class-wide benefit or direct superiority. Study participants and reports are not added together.", "missingness": "Positive or null results for other drugs are not used as independent NATALEE replication, zero ribociclib effect, class-wide benefit or direct superiority. Study participants and reports are not added together.", "uncertainty": "Unread, immature or unverified does not mean zero effect, zero events, safety or a new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Positive or null results for other drugs are not used as independent NATALEE replication, zero ribociclib effect, class-wide benefit or direct superiority. Study participants and reports are not added together." }, { "item_id": "N21", "question_type": "Comparative efficacy", "question": "Are Novartis, TRIO, unreported public support and company roles distinguished?", "needed": "Cash, drugs or in-kind support, affiliations, external analysis, supervision and writing roles", "role": "Required", "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries", "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.", "criterion": "Cash, drugs or in-kind support, affiliations, external analysis, supervision and writing roles", "basis": "Longer overall survival", "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions", "proposed_research": "Obtain original disclosures of funding, supply, affiliations, supervision, analysis and writing separately.", "current_reports": [ "R01", "R02" ], "existence": "Material information recorded in the preserved review summary", "acquired_read": "Summary read; external materials not read", "observation": "NATALEE was supported by Novartis and co-supervised by TRIO; the existing Korean article records no separate public grant as reported.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials remain unread and review of existing content remains incomplete. TRIO supervision is not converted into certification of funding, drug supply or analytical independence. Details of drug or in-kind provision, employee authors, external analysis and writing roles are absent from the existing review summary or unread.", "missingness": "TRIO supervision is not converted into certification of funding, drug supply or analytical independence. Details of drug or in-kind provision, employee authors, external analysis and writing roles are absent from the existing review summary or unread.", "uncertainty": "Unread, immature or unverified does not mean zero effect, zero events, safety or a new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "TRIO supervision is not converted into certification of funding, drug supply or analytical independence. Details of drug or in-kind provision, employee authors, external analysis and writing roles are absent from the existing review summary or unread." }, { "item_id": "N22", "question_type": "Comparative efficacy", "question": "Are funding and independence information for other-drug trials kept within their original scope?", "needed": "Each trial's funding, in-kind support, authors, analysis and roles", "role": "Required", "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries", "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.", "criterion": "Each trial's funding, in-kind support, authors, analysis and roles", "basis": "Longer overall survival", "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions", "proposed_research": "Obtain each trial's original support, products, affiliations, analysis and writing relationships.", "current_reports": [ "R01", "R02", "R04", "R03", "R05" ], "existence": "Material information recorded in the preserved review summary", "acquired_read": "Summary read; external materials not read", "observation": "Original funding information records Pfizer and cooperative study groups for PALLAS, the GBG and Pfizer development program for PENELOPE-B, and Eli Lilly for monarchE.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials remain unread and review of existing content remains incomplete. Participation of study groups alone does not newly certify absence of company in-kind support or employee authors, or independence of external analysis. Original role details have not been read.", "missingness": "Participation of study groups alone does not newly certify absence of company in-kind support or employee authors, or independence of external analysis. Original role details have not been read.", "uncertainty": "Unread, immature or unverified does not mean zero effect, zero events, safety or a new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Participation of study groups alone does not newly certify absence of company in-kind support or employee authors, or independence of external analysis. Original role details have not been read." }, { "item_id": "N23", "question_type": "Supplementary harm evidence", "question": "What collection gaps remain for neutropenia, liver-related adverse events and QT prolongation?", "needed": "Each harm's definition, grade, people or events, original denominators, exposure and relatedness", "role": "Required", "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries", "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.", "criterion": "Each harm's definition, grade, people or events, original denominators, exposure and relatedness", "basis": "Longer overall survival", "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions", "proposed_research": "Obtain original harm types, grades, collection, group denominators, exposure, relatedness and discontinuation.", "current_reports": [ "R01", "R02" ], "existence": "Material information recorded in the preserved review summary", "acquired_read": "Summary read; external materials not read", "observation": "The stored safety record lists neutropenia, liver-related adverse events and QT prolongation; the parent's safety status is Caution.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials remain unread and review of existing content remains incomplete. No new harm rates, grades, risk differences, P, CI, safety ranking or monitoring instructions are created. Original details of people or events, collection, denominators and relatedness have not been read.", "missingness": "No new harm rates, grades, risk differences, P, CI, safety ranking or monitoring instructions are created. Original details of people or events, collection, denominators and relatedness have not been read.", "uncertainty": "Unread, immature or unverified does not mean zero effect, zero events, safety or a new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "No new harm rates, grades, risk differences, P, CI, safety ranking or monitoring instructions are created. Original details of people or events, collection, denominators and relatedness have not been read." }, { "item_id": "N24", "question_type": "Supplementary harm evidence", "question": "Are harm-related discontinuation, dose reduction, actual exposure and ITT distinguished?", "needed": "Original discontinuation, dose reduction, adherence, exposure, harms and event mapping", "role": "Required", "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries", "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.", "criterion": "Original discontinuation, dose reduction, adherence, exposure, harms and event mapping", "basis": "Longer overall survival", "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions", "proposed_research": "Obtain original actual exposure, harm-related discontinuation, dose reduction, adherence, follow-up and event connections.", "current_reports": [ "R01", "R02" ], "existence": "Material information recorded in the preserved review summary", "acquired_read": "Summary read; external materials not read", "observation": "The stored summary records planned exposure of 3 years and ITT analysis, and describes harm types.", "condition_status": "Unverified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials remain unread and review of existing content remains incomplete. These do not support new calculations of exposure completion for everyone, discontinuation rates, adherent-participant effects or survival differences caused by harms.", "missingness": "These do not support new calculations of exposure completion for everyone, discontinuation rates, adherent-participant effects or survival differences caused by harms.", "uncertainty": "Unread, immature or unverified does not mean zero effect, zero events, safety or a new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "These do not support new calculations of exposure completion for everyone, discontinuation rates, adherent-participant effects or survival differences caused by harms." }, { "item_id": "N25", "question_type": "Supplementary harm evidence", "question": "Are rare or long-term harms and replication of harms in other drugs kept from being newly established?", "needed": "Long-term harms, exposure, duration, denominators and direct drug-specific comparisons", "role": "Required", "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries", "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.", "criterion": "Long-term harms, exposure, duration, denominators and direct drug-specific comparisons", "basis": "Longer overall survival", "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions", "proposed_research": "Obtain drug-specific direct harm, long-term exposure, collection, denominator and follow-up materials.", "current_reports": [ "R01", "R02", "R03", "R04", "R05" ], "existence": "Material information recorded in the preserved review summary", "acquired_read": "Summary read; external materials not read", "observation": "The currently designated stored summary records some harm types and still-immature OS, while other-drug trials are used as iDFS contrasts.", "condition_status": "Unverified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials remain unread and review of existing content remains incomplete. Absence of harm tables is not converted to absence of rare harms or long-term safety, and iDFS findings for other drugs do not certify identical harms. No treatment, monitoring or dose recommendations are created.", "missingness": "Absence of harm tables is not converted to absence of rare harms or long-term safety, and iDFS findings for other drugs do not certify identical harms. No treatment, monitoring or dose recommendations are created.", "uncertainty": "Unread, immature or unverified does not mean zero effect, zero events, safety or a new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Absence of harm tables is not converted to absence of rare harms or long-term safety, and iDFS findings for other drugs do not certify identical harms. No treatment, monitoring or dose recommendations are created." }, { "item_id": "N26", "question_type": "Comparative efficacy", "question": "Are original registration, three bibliography URLs and two evidence records without bibliography distinguished?", "needed": "Each report, existing links, registration identifiers and access status", "role": "Required", "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries", "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.", "criterion": "Each report, existing links, registration identifiers and access status", "basis": "Longer overall survival", "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions", "proposed_research": "Connect additional user-provided original materials by report type, bibliography and actual access status.", "current_reports": [ "R01", "R02", "R03", "R04", "R05" ], "existence": "Material information recorded in the preserved review summary", "acquired_read": "Summary read; external materials not read", "observation": "The three existing citations provide NATALEE interim and final URLs and a PENELOPE-B URL, while PALLAS and monarchE have only existing evidence-list information. Each original registration identifier is preserved.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials remain unread and review of existing content remains incomplete. No new bibliography, DOI or URL is created for PALLAS or monarchE. External abstracts, full texts, registration, protocols and SAP remain unread; separate link testing was not performed.", "missingness": "No new bibliography, DOI or URL is created for PALLAS or monarchE. External abstracts, full texts, registration, protocols and SAP remain unread; separate link testing was not performed.", "uncertainty": "Unread, immature or unverified does not mean zero effect, zero events, safety or a new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "No new bibliography, DOI or URL is created for PALLAS or monarchE. External abstracts, full texts, registration, protocols and SAP remain unread; separate link testing was not performed." }, { "item_id": "N27", "question_type": "Comparative efficacy", "question": "Are Korean and English articles, axes, reference dates, corrections, empty values and preparation status preserved?", "needed": "Distinguishing the entire parent, selected subclaim, original languages and history from the current preparation", "role": "Supplementary", "role_reason": "An individual preparation condition recording the selected claim, comparison, endpoint, denominator, timing and interpretation boundaries", "application_exception": "Unread external materials, other drugs or questions, and outcomes outside the scope do not substitute for fulfillment, zero effect or safety.", "criterion": "Distinguishing the entire parent, selected subclaim, original languages and history from the current preparation", "basis": "Longer overall survival", "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions", "proposed_research": "Preserve original texts before connecting additional user materials or decisions as separate events.", "current_reports": [ "R01", "R02" ], "existence": "Material information recorded in the preserved review summary", "acquired_read": "Summary read; external materials not read", "observation": "2026-08-26, empty correction and deliberation records, the parent's B76/Caution, axes, Korean and English articles, subclaim B/D and notes are preserved as recorded.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials remain unread and review of existing content remains incomplete. Original B0, registration agreement and confirmatory wording are historical records, not new review certification. Subclaim absences are not filled; original pending-review or preparation-eligibility indicators are candidate history.", "missingness": "Original B0, registration agreement and confirmatory wording are historical records, not new review certification. Subclaim absences are not filled; original pending-review or preparation-eligibility indicators are candidate history.", "uncertainty": "Unread, immature or unverified does not mean zero effect, zero events, safety or a new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original B0, registration agreement and confirmatory wording are historical records, not new review certification. Subclaim absences are not filled; original pending-review or preparation-eligibility indicators are candidate history." } ], "reports": [ { "report_id": "R01", "title": "Slamon D, et al. N Engl J Med. 2024;390:1080-1091. PMID: 38507751.", "url": "https://pubmed.ncbi.nlm.nih.gov/38507751/", "report_type": "Report linked through an existing citation", "existence": "Preserved information from the existing citation and evidence lists", "acquired_read": "Summary read; external materials not read", "study_family": "F01", "independent_replication": false, "observed_result": "Three-year rates 90.4% versus 87.1%, HR 0.75(95% CI 0.62~0.91), P=.003; final events 226 versus 283, HR 0.749(0.628~0.892), P=.0012", "result_level": "The two reports from the same NATALEE trial share the integrated evidence-list results; this is not a comparison with each external report", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "local_summary", "public_status": "Existing link preserved", "access_status": "Summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Stored parent-verdict summary" }, { "material_type": "abstract", "public_status": "Existing link preserved", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; a URL does not mean acquisition, reading or completed review" }, { "material_type": "fulltext", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; a URL does not mean acquisition, reading or completed review" }, { "material_type": "registration", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; a URL does not mean acquisition, reading or completed review" }, { "material_type": "protocol_sap", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; a URL does not mean acquisition, reading or completed review" } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/38507751/" } ] }, { "report_id": "R02", "title": "Hortobagyi GN, et al. Ann Oncol. 2025;36:149-157. PMID: 39442617.", "url": "https://pubmed.ncbi.nlm.nih.gov/39442617/", "report_type": "Report linked through an existing citation", "existence": "Preserved information from the existing citation and evidence lists", "acquired_read": "Summary read; external materials not read", "study_family": "F01", "independent_replication": false, "observed_result": "Three-year rates 90.4% versus 87.1%, HR 0.75(95% CI 0.62~0.91), P=.003; final events 226 versus 283, HR 0.749(0.628~0.892), P=.0012", "result_level": "The two reports from the same NATALEE trial share the integrated evidence-list results; this is not a comparison with each external report", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "local_summary", "public_status": "Existing link preserved", "access_status": "Summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Stored parent-verdict summary" }, { "material_type": "abstract", "public_status": "Existing link preserved", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; a URL does not mean acquisition, reading or completed review" }, { "material_type": "fulltext", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; a URL does not mean acquisition, reading or completed review" }, { "material_type": "registration", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; a URL does not mean acquisition, reading or completed review" }, { "material_type": "protocol_sap", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; a URL does not mean acquisition, reading or completed review" } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/39442617/" } ] }, { "report_id": "R03", "title": "Loibl S, et al. J Clin Oncol. 2021. PMID: 33793299.", "url": "https://pubmed.ncbi.nlm.nih.gov/33793299/", "report_type": "Report linked through an existing citation", "existence": "Preserved information from the existing citation and evidence lists", "acquired_read": "Summary read; external materials not read", "study_family": "F03", "independent_replication": false, "observed_result": "HR 0.93(95% repeated CI 0.74~1.17), P=.525", "result_level": "Other-drug results in the existing evidence list; not independent replication of ribociclib", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "local_summary", "public_status": "Existing link preserved", "access_status": "Summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Stored parent-verdict summary" }, { "material_type": "abstract", "public_status": "Existing link preserved", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; a URL does not mean acquisition, reading or completed review" }, { "material_type": "fulltext", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; a URL does not mean acquisition, reading or completed review" }, { "material_type": "registration", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; a URL does not mean acquisition, reading or completed review" }, { "material_type": "protocol_sap", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; a URL does not mean acquisition, reading or completed review" } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/33793299/" } ] }, { "report_id": "R04", "title": "PALLAS palbociclib trial", "url": null, "report_type": "Study information recorded in the existing evidence list; bibliography not acquired", "existence": "Only existing evidence-list information is available; no separate citation", "acquired_read": "Summary read; external materials not read", "study_family": "F02", "independent_replication": false, "observed_result": "No added benefit from palbociclib", "result_level": "Other-drug results in the existing evidence list; not independent replication of ribociclib", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "local_summary", "public_status": "Existing link preserved", "access_status": "Summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Stored parent-verdict summary" }, { "material_type": "abstract", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; a URL does not mean acquisition, reading or completed review" }, { "material_type": "fulltext", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; a URL does not mean acquisition, reading or completed review" }, { "material_type": "registration", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; a URL does not mean acquisition, reading or completed review" }, { "material_type": "protocol_sap", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; a URL does not mean acquisition, reading or completed review" } ], "links": [] }, { "report_id": "R05", "title": "monarchE abemaciclib trial", "url": null, "report_type": "Study information recorded in the existing evidence list; bibliography not acquired", "existence": "Only existing evidence-list information is available; no separate citation", "acquired_read": "Summary read; external materials not read", "study_family": "F04", "independent_replication": false, "observed_result": "Four-year rates 85.8% versus 79.4%, HR 0.664(95% CI 0.578~0.762)", "result_level": "Other-drug results in the existing evidence list; not independent replication of ribociclib", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "local_summary", "public_status": "Existing link preserved", "access_status": "Summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Stored parent-verdict summary" }, { "material_type": "abstract", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; a URL does not mean acquisition, reading or completed review" }, { "material_type": "fulltext", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; a URL does not mean acquisition, reading or completed review" }, { "material_type": "registration", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; a URL does not mean acquisition, reading or completed review" }, { "material_type": "protocol_sap", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; a URL does not mean acquisition, reading or completed review" } ], "links": [] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed." } ], "status_dictionary": { "Partly verified": "Some information exists in the preserved review summary, with detailed original materials still unverified; no certification of a passed review or clinical efficacy", "Unverified": "Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety", "Review incomplete": "Existing content review pending", "Met": "Use only within the relevant conditions after existing content review; no automatic designation in this preparation", "Not reported": "Distinguish only within materials actually read; do not turn unread external materials into unreported findings", "Inaccessible": "Not applied during this preparation because actual access was not tested", "Not applicable": "Use with a reason for non-applicability based on an explicit question boundary", "Conflicting data": "Judge after actual material comparison; review was not performed during this preparation", "Insufficient evidence for the conditions": "Do not use as a clinical grade encompassing currently unread materials" }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "The same NATALEE interim and final iDFS reports share a population and two subclaim questions. PALLAS palbociclib contrasts results for another drug and is not independent replication of ribociclib or a direct comparison between drugs. PENELOPE-B palbociclib contrasts results for another drug and is not independent replication of ribociclib or a direct comparison between drugs. monarchE abemaciclib contrasts results for another drug and is not independent replication of ribociclib or a direct comparison between drugs. Family IDs connect report relationships and do not certify independent counts; the same population, sibling questions, follow-up reports and participants receiving other drugs are not newly added as independent observations." }, "history": [ { "date": "2026-10-10", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public pages and materials were prepared from the existing 27 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-10" }